Home   Our Team   Certifications   Customers   Contact  
 
             
     
Pre-formulation and formulation development
     

Nextar pharmaceutical development team offers a wide range of preformulation and formulation development to achieve a successful dosage form development. Formulations are rationally designed and developed to ensure and enhance product stability and meet the specific product specifications defined by the client.
 
Our Formulation labs are fully equipped with all the required modern instrumentation and in silico tools to calculate and determine experimentally all the physicochemical properties of drug candidates. The most appropriate excipients and ingredients are selected in order to be compatible with the drug and to preserve its pharmacological efficacy within the dosage form.
 
Nextar pharmaceutical scientists have vast experience and expertise in formulating poorly water soluble drugs using a range of non-proprietary solubility enhancement techniques and formulation strategies.
 
Our formulation development services include:

  • Pre-formulation studies, determination of physicochemical properties using in-silico tools (log P, log D, pKa), particle size distribution, zeta potential.
  • Drug solubility in aqueous media and organic solvents.
  • Hygroscopicity studies.
  • Compatibility studies for excipients and packaging materials.
  • Dissolution tests of drug products in simulated gastric and intestinal fluids.
  • Formulation development of a wide variety of dosage forms
  • injectables, ophthalmic solutions, lyophilized powders, topical creams, ointments, gels, suspensions, emulsions, capsules, tablets.
  • Formulation strategies for solubility enhancement and improvement of bioavailability by drug complexation with cyclodextrins or solubilization with surfactants and cosolvents.
  • Formulation of slow-release and controlled-release drug delivery systems.
  • Drug encapsulation in liposomes and nanoparticles.
  • Formulation and production of batches for stability testing.
  • Formulation of test articles and preparation for preclinical efficacy, pharmacokinetics and toxicology studies.
  • Commercial formulation development

     

     

     

     

     

     

     

     

     

     

     

     

 

News


Nextar has completed the integration of a new Ion-exchange chromatograph.
The new device allows the separation of ions and polar molecules based on their charge. It can be used for almost any kind of charged molecule including large proteins, small nucleotides and amino acids (November 2011)
A new service - QP release of imported pharmaceutical batches
Following the ministry of health new regulation, as of April 2011, the release of imported batches manufactured in a country that is not accredited by the International Laboratory Accreditation Cooperation, is under the responsibility of the importer. The batches must be tested and released by a GMP laboratory in an accredited country. Nextar invites all importers to use our QP and Analytical services.
A new Corona Charged Aerosol Detector (CAD) for HPLC
Nextar has completed the integration of a novel universal HPLC detector, the Corona Charged Aerosol Detector (CAD) and has successfully completed the validation of an analytical method for assay and IDD of phospholipids. Based on a unique, innovative detection method, the Corona detector is a robust universal detector with sensitivity that is similar and often better than ELSD. This makes it ideal for determination of low-level impurities, studies of leachables and extractables, or just assay of analytes that are not suitable for UV detection (e.g. phospholipids, carbohydrates etc.).
 
 
       
  Design - Studiommoza

Powered by Team-AT